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Sunday, November 18, 2012

An Insider’s Perspective on the FDA Regulatory Process

American Academy of Orthopaedic Surgeons

Madeleine Lovette

The U.S. Food and Drug Administration (FDA) is integral to ensuring that innovative orthopaedic drugs and devices reach musculoskeletal patients in a safe and timely manner. The FDA Center for Devices and Radiological Health (CDRH) Medical Device Fellowship Program (MDFP) provides opportunities for health professionals, including orthopaedic surgeons, to participate in the FDA regulatory process for medical devices.

Participants in the MDFP contribute to FDA activities by conducting device reviews, developing guidance documents and regulatory policy, providing expert consultation, conducting research, and participating in postmarket activities. By providing expertise and communicating a user’s experience, they enhance the efficiency and effectiveness of the FDA regulatory process.

Faisal Mirza, MD, FRCSC

Faisal Mirza, MD, FRCSC, a fellow of both the AAOS and the American Orthopaedic Society for Sports Medicine, is currently serving in the MDFP. He recently sat down with AAOS Now to discuss his participation and how it has changed his understanding of the regulatory process and the way he practices orthopaedic surgery.

AAOS Now: What made you decide to seek out this fellowship?Dr. Mirza: I had been involved in device design consulting with various companies and investment firms and even hold a patent on a medical device. One issue that would always come up was the FDA regulatory process—questions about device development, trial design, and device clearance or approval. In addition, while I was an attending faculty member at Stanford University and the VA Palo Alto Health Care System in California, I became quite active in designing clinical trials, developing preclinical and clinical research protocols, and collaborating on innovative multidisciplinary scientific efforts and grant submissions, most of which were related to orthopaedic surgery and involved some type of medical device or implant.

As a result, I became very interested in learning more about the FDA review process and the regulation of medical devices. I have always enjoyed new challenges and exploring uncharted territories, and the FDA was a big black box that I really wanted to open. When I found out about the MDFP, I knew it would be a perfect fit.

AAOS Now: What have you learned in your fellowship thus far?Dr. Mirza: This fellowship has really made me realize how important the FDA is in enabling and ensuring patient safety. I have a greater appreciation of the impact of devices on patient safety and efficacy. As orthopaedic surgeons, we use devices, rods, and plates all of the time, but we don’t necessarily know much about device engineering and the regulatory approval process. Now, I have a better understanding of how drugs and devices are cleared or approved and enter the market. That’s increased my confidence in the approach I use in selecting devices for my patients.

As surgeons, we are taught quite well how to do surgery and use devices. However, regularly and carefully inspecting the “Instructions for Use” package insert on every device is something we may rarely do; we assume that our training taught us all we need to know. I now realize how significant and important the package insert information can be.

AAOS Now: Are you still practicing medicine during your fellowship?Dr. Mirza: Yes, I have a lot of flexibility and I continue to perform surgery and some clinical work. The FDA actually promotes and provides you with professional development time so that medical officers, as we are called, can sustain our clinical skills.

When I first started, I primarily focused on FDA work and learning but now I am engaging in more clinical work, along with performing file reviews. When I can, I attend clinical rounds and conferences at MedStar Union Memorial Hospital in Baltimore. The orthopaedic program there is led by Leslie S. Matthews, MD, MBA, who has a great relationship with the FDA. I also lecture at the National Institutes of Health to residents and medical students. Physicians who work at the FDA permanently can work part time so that they can both serve the public and maintain their clinical acumen.

AAOS Now: Has this fellowship changed the way you practice medicine? Dr. Mirza: Yes. I definitely use more scrutiny and caution in terms of the intended use of a device, how it is made, and from what materials it is constructed. I am much more conscientious about how some medical comorbidities factor in to device selection or associated device-related adverse events. I’m also more aware of patient-specific issues such as osteoporosis, poor bone quality, gender, and other variables that can affect how a device functions.

I have also significantly increased the precision and comprehensive nature of device appraisal with public health and safety in mind, including the basis of its design and development strategy and material construct and the preclinical and clinical data used to support its approval. I also read package inserts more often.

[added by Connie/Interesting that most surgeons don't read the device inserts nor apparently to do they really pay attention to how a device is made and from what material it is constructed. I just happened to run across today,

AAOS Now: What have you had the opportunity to do at the FDA? Dr. Mirza: I have been providing clinical consults, reviews, and memoranda on various submissions of predominately orthopaedic implants, as well as some nonorthopaedic devices and combination products. A clinical consult is an expert opinion on the clinical aspects of a submission—whether it’s a 510(k) premarket notification submission or the more in-depth premarket approval (PMA) submission. This can include clinical trial design, device design, clinical outcomes, intended use or indications for use for a device, regulatory history, and changes resulting from the recently updated roadmap in current regulation and device law.

I also received a generous research grant and am the principal investigator on an orthopaedic device-related outcomes project at the FDA. The goals of this project are to understand both the metrics of orthopaedic outcomes in device-related orthopaedic surgery as determined by patient-reported outcomes and the minimum clinically important difference across patient variables. In particular, I am focusing on age, gender, body mass index, race/ethnicity, and other factors. I also participate in various scientific and research endeavors in regulation and innovation.

AAOS Now: How do you think that medical device development can be enhanced?Dr. Mirza: The challenge I see for device development is in the balance of regulations and scientific innovations. To achieve this balance, we need to establish meaningful relationships across paradigms and disciplines. Regulators, innovators, engineers, healthcare providers, patients, insurance carriers, and others must work to bridge communication gaps.

Sometimes, fear and a lack of understanding of the process makes device regulation more complex than it needs to be. Increased communication and open dialogue during the development of a medical device can lead to a better understanding of what data are needed to show safety and effectiveness and provide for a less cumbersome, seamless system that can reduce the burden of bench-to-bedside timeliness. This is the principle reflected in the mission of the FDA.

Union Memorial Hospital is a great example of bridging that gap by allowing residents to spend time in their senior year at the FDA providing clinical opinions on device submissions. Another example is effective public/private partnerships that build relationships across regulatory and scientific frameworks and lead to innovative strategies and solutions.

AAOS Now: Would you recommend this fellowship to your orthopaedic colleagues?Dr. Mirza: Absolutely. I think the experience that I have gained at the FDA is priceless. You cannot read in a textbook or be fully aware of the process from a seminar. From the didactic training and the on-the-job reviewing to the ongoing mentorship, this fellowship provides so much opportunity to expand knowledge and experience. It opens doors in directions that would have otherwise remained unexplored. It is an invaluable experience that I would strongly encourage others to pursue.Madeleine Lovette is the communications specialist in the AAOS office of government relations; she can be reached at lovette@aaos.org